We’ve been covering Abbott‘s MitraClip mitral valve repair system since 2004, when it was still a product of Evalve Inc. of Redwood City, CA. After a rocky regulatory path, in March the FDA’s Circulatory System Devices Panel recommended approval of the device and now the MitraClip has finally received final FDA approval to come to market. The device has been cleared for use in Europe for five years now.

The MitraClip is designed to repair diseased mitral valves to improve regurgitation without resorting to open heart surgery, allowing for a therapeutic option for patients that may otherwise not be good candidates for an open sternotomy bypass procedure.